The present randomized,
double-blind, controlled clinical trial investigated the efficacy and safety of
a 10% Phyllanthus emblica (Amla) oral spray in managing hyposalivation among 60
diabetic patients, comparing it with a commercially available methylcellulose
spray.
Participants were
randomly allocated into two groups and followed for one month, with assessments
of unstimulated and stimulated salivary flow, pH, taste perception, total
salivary protein, and quality of life using the OHIP-14 and Xerostomia
Inventory.
The Phyllanthus emblica
spray was formulated using a crude ethanolic extract of the fruit, which
underwent rigorous phytochemical screening confirming the presence of
alkaloids, flavonoids, phenols, and tannins.
Testing included DPPH
antioxidant assays (showing a high scavenging activity of 88.78%),
antibacterial assays (demonstrating up to 52.21% inhibition against E. coli),
and MTT cytotoxicity assays to confirm a non-toxic cell viability of over 80%.
The final intervention was prepared at a 10% concentration in a Carbopol 940
base, adjusted to a neutral pH of 6.8–7.0.
Statistical analysis
included both intergroup and intragroup comparisons across four evaluation
periods (baseline, week 1, week 2, week 3 and week 4). Independent t-tests were
employed to compare the mean salivary flow rates and protein levels between the
Phyllanthus emblica and methylcellulose groups. Within each group, paired
t-tests or repeated measures ANOVA were used to evaluate changes from baseline
through the weekly follow-ups. Subjective data from OHIP-14 and Xerostomia
Inventory were analysed to assess improvements in quality of life. The results
showed statistically significant improvements in salivary flow rates and
subjective comfort in the Amla group compared to the control.
The study demonstrated
that the 10% Amla spray is a safer, more effective, and well-tolerated
alternative for managing diabetic hyposalivation and has addressed both
physiological and patient-centred outcome.
Future research with
larger sample sizes and longer follow-up is recommended to further validate
these findings